510(k) · Cleared
ClearedDermadapt Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pegasus Biologics, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Sep 21, 2006 as substantially equivalent to K040283 (Euroresearch Srl, 2005) and 1 other predicate after a 113-day review. Its family tree reaches back 3 generations to 1988. 26 later devices descend from it.
- Decided
- Sep 21, 2006
- Review
- 113 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K881854 (1988). 10 ancestors in all. 26 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 2 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 1 generation backK040283 BiopadEuroresearch Srl · 2005
- This deviceK061494 Dermadapt Wound DressingPegasus Biologics, Inc. · 2006
- Descendant · cites it directly · 25 of its ownK071425 Unite BiomatrixPegasus Biologics, Inc. · 2007
- Descendant · 2 generations on · 19 of its ownK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 7 of its ownK082103 LTM Wound DressingLifecell Corp. · 2008
- Descendant · 3 generations on · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
- Descendant · 3 generations on · 4 of its ownK200502 Myriad ParticlesAroa Biosurgery, Ltd. · 2021
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K071425Unite BiomatrixPegasus Biologics, Inc. · 2007 · cites it directly25descendants
- K092096Endoform Dermal TemplateMesynthes, Ltd. · 2010 · 2 generations on19descendants
- K082103LTM Wound DressingLifecell Corp. · 2008 · 2 generations on7descendants
- K132343Marigen Wound DressingKerecis Limited · 2013 · 3 generations on5descendants
- K200502Myriad ParticlesAroa Biosurgery, Ltd. · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −2 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −1 | K040283 | Biopad | Euroresearch Srl | 2005 | — |
| 0 (this device) | K061494 | Dermadapt Wound Dressing | Pegasus Biologics, Inc. | 2006 | — |
| +1 | K071425 | Unite Biomatrix | Pegasus Biologics, Inc. | 2007 | — |
| +2 | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | 3 |
| +2 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| +3 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| +3 | K200502 | Myriad Particles | Aroa Biosurgery, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040283 | BiopadSummary page 1…many commercially available collagen-based wound dressings. Two specific predicate devices are BIOPAD® (Euroresearch S.R.L.) cleared under Premarket Notification Number K040283 and StimulenTM Collagen (Southwest Technologies, Inc.) cleared under Premarket Notification Number K030774. DEVICE DESCRIPTION Th… | 2005 |
| * | K030774 | Stimulen CollagenSummary page 1…roresearch S.R.L.) cleared under Premarket Notification Number K040283 and StimulenTM Collagen (Southwest Technologies, Inc.) cleared under Premarket Notification Number K030774. DEVICE DESCRIPTION The Pegasus Biologics DermADAPT M T Wound Dressing is a decell… | 2004 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071425 | Unite Biomatrix | 2007 | 25 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K071425 (Pegasus Biologics, Inc., 2007) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K040283.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
The Pegasus Biologics DermADAPT TM Wound Dressing is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
* Partial and full thickness wounds,
* Draining wounds,
* Pressure sores/ulcers,
* Venous ulcers,
* Chronic vascular ulcers,
* Diabetic ulcers,
* Trauma wounds (e.g., abrasions, lacerations, partial thickness bums, skin tears),
* Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061494: Dermadapt Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061494
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026